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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Anti-adalimumab antibodies kinetics: an early guide for juvenile idiopathic arthritis (JIA) switching

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Brunelli, Juliana Barbosa [1] ; Silva, Clovis Almeida [1] ; Pasoto, Sandra Gofinet [2] ; Schahin Saa, Carla Goncalves [2] ; Kozu, Katia Tomie [1] ; Goldenstein-Schainberg, Claudia [2] ; Leon, Elaine Pires [2] ; Vendramini, Margarete B. G. [2] ; Fontoura, Nicole [2] ; Bonfa, Eloisa [2] ; Aikawa, Nadia Emi [1, 2]
Total Authors: 11
[1] Univ Sao Paulo, Fac Med, Pediat Rheumatol Unit, Hosp Clin HCFMUSP, Sao Paulo, SP - Brazil
[2] Univ Sao Paulo, Fac Med, Div Rheumatol, Hosp Clin HCFMUSP, Ave Dr Arnaldo, 455, 3rd Floor, BR-05403010 Sao Paulo, SP - Brazil
Total Affiliations: 2
Document type: Journal article
Web of Science Citations: 1

Objective To assess the longitudinal production of anti-adalimumab antibody (AAA) and baseline risk factors for this antibody development in juvenile idiopathic arthritis (JIA) patients initiating adalimumab (ADA). Method Thirty consecutive JIA patients under ADA therapy were prospectively followed. JIA clinical/laboratorial/treatment data and sera for ADA and AAA assays (ELISA and bridging ELISA) were obtained at baseline (BL), 2 months (2M), 3 months (3M), 6 months (6M), 12 months (12M), and 24 months (24M). Patients with therapy failure requiring ADA withdrawn had their sera evaluated at their last medical visit prior to biologic switch (blinded to ADA and AAA levels). Results AAA was absent at BL, first detected at 2M after ADA initiation in 2/30 (7%) patients with a significant increase at 3M (10/29 (34%), p = 0.013) and no major change in 6M (11/30 (37%)) and 12M (9/26 (35%)). Of note, at 3M, AAA levels correlated negatively with ADA levels (r = - 0.781, p = 0.0001). Analysis of BL predictors revealed a significantly higher risk of developing AAA in patients with female gender (OR 21; 95% CI 1.08-406.57; p = 0.044), ESR > 30 mm/1st hour (OR 5.44; 95% CI 1.04-28.53; p = 0.045), and leflunomide use (OR 9.33; 95% CI 1.51-57.66; p = 0.016). In contrast, concomitant use of methotrexate was protective for AAA appearance (OR 0.08; 95% CI 0.01-0.53; p = 0.009). After 12M of ADA, 60% of AAA-positive patients required drug switch for drug failure compared with 15% in AAA-negative group (p = 0.03). Conclusions This study provides novel evidence of AAA production kinetics demonstrating a timely significant increase starting at 3M and stable throughout 24M. We also identified female gender, increased ESR, and leflunomide use as relevant risk factors for AAA production at BL, whereas methotrexate was protective. Early systematic monitoring of AAA at 3M may, therefore, guide drug switching in these patients. (AU)

FAPESP's process: 15/03756-4 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy
Grantee:Eloisa Silva Dutra de Oliveira Bonfá
Support type: Research Projects - Thematic Grants